IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S— 510(k) K980331

Name: FDA 510(k) clearance K980331
Creator: U.S. Food and Drug Administration
Published: 1998-03-16

Substantially Equivalent

More Diagnostics

FDA 510(k) clearance K980331 for IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S, Substantially Equivalent on 1998-03-16. Applicant: More Diagnostics. Device class: 1.

Clearance details

Applicant: More Diagnostics
Product code: Code DIF
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1998-01-28
Decision date: 1998-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Osos, CA, US

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